Table 2.
Observational studies investigating the impact of Peginterferon in HBV/HDV infection.
| Authors Years |
Type of study | Enrollment period | Sample size | Age at enrollment (mean or median and range) |
Follow up | Intervention group treatment | Control group treatment | HBsAg loss at the EOFU+ | AST/ALT Normalization at the EOFU+ | HDV-RNA Undetectability at the EOFU+ | Common adverse event |
|---|---|---|---|---|---|---|---|---|---|---|---|
| ( Karaca et al., 2013 ) | Observational, single-center, prospective cohort study | 2003-2010 | 32 | 18-65 | 19.5 months (± 14.4) | PEG-IFN£ alfa | – | 0(0%) | 16(50%) | 15(47%) | Leukopenia, thrombocytopenia and fatigue. |
| ( Abbas et al., 2014 ) | Observational, multicentric, prospective cohort study | 2009-2011 | 104 | 30 (15-55) | 72 weeks | 69 pts PEG-IFN£-α2a 35 pts PEG-IFN£-α2b |
– | – | ALT normalization in 38 pts (35%) | 44 pts (42.3%) | Non-serious adverse events and laboratory abnormalities leading to dose modifications or discontinuation. |
| ( Abbas et al., 2014 ) | Observational, single-center, prospective case-control study | 2008-2011 | 20 | 43.7 ± 1.2 | end of follow up not defined | 14 pts (Group A) IFN**-α2a for 1 year; 6 pts (Group B) IFN**-α2a for 3 years. |
– | – | ALT decreased at the EOT ç in responders, but increased at the end of FU $ | Group A 1 (7.1%) Group B 2 (33.3%) |
Anorexia, weakness, and weight loss |
| ( Bahcecioglu et al., 2015 ) | Observational, single- center, retrospective study | 2004-2012 | 56 | 47.6 ± 9.5 Vs 51.1 ± 12.4 |
24 weeks after EOT ç | 15 pts PEG-IFN £ alfa 2b | 41 pts PEG-IFN £ alfa-2a | – | Total patients: 19(32.2%) | Interventional group: 2(13.3%) Control group: 9(22%) |
7 (12.5%) patients discontinued |
| ( Soyer et al., 2016 ) | Observational, retrospective cohort study | 2000-2011 | 65 | 36 ± 9.06 Vs 42.1 ± 11.4 |
Median 12 months in group 1 and 16 months in group 2 | Group 1 ≤12 months of IFN therapy | Group 2 >12 months of IFN therapy (max 24 months) | – | Group 1: 4(27%) Group 2: 25(49%) |
Group 1: 1 (7%) Group 2: 19(37%) |
Thrombocytopenia and leukopenia 14% in group 1 (dose reduction in 1 patient), 18% in group 2 (dose reduction in 7 patients, interruption in 1 patient for 4 weeks). Flu-like symptoms 7% in group 1 and 18% in group 2. Depression 7% in group 1, 0% in group 2. Weakness 0% in group 1 and 18% in group 2. Myalgia 0% in group 1 and 4% in group 2. |
| ( Niro et al., 2016 ) | Observational, retrospective, multicentric study | 62 | 53 + 11 | 5 year after EOTç | PEG-IFN £ with or without NUCs§ | – | 14 (22.6%) | – | 26 (41.9%) | ||
| ( Wranke et al., 2017 ) | Observational, retrospetive, single center, cohort study | 1987-2013 | 136 | 37.6 (14.1- 61.3) |
5,2 y (0,6-18,8 y) | 52 pts IFN** α (30 with NUCs§) | 39 pts no treatment 45 pts NUCs§ (30 with IFN** α) |
8 pts in IFN**α 1 pt in NUCs§ 1 spontaneously |
– | IFN**α vs NUCs§ CI: 1.3-3.0 p<0,01 IFN**α vs untreated CI: 1,1-2,3 p<0.03 |
– |
| ( Boglione et al., 2019 ) | Observational, retrospective, single-center, cohort study | 2007-2014 | 46 | 33 (27–41) | 3 years | PEG-IFN £ alfa 180 mcg | – | 4(8.7%) | 8(17.4%) | Hematological toxicity (60.9%) [including neutropenia (41.3%), anemia (375), thrombocytopenia (30.4%)], Fatigue (52.2%), Flu-like syndrome (45.6%). |
*End of follow up; ** Interferon; £Peginterferon; $follow up; ç End of treatment, §nucleos(t)ide analogues